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NCT Number: NCT04595916

Efficacy and Safety of Polyene Phosphatidylcholine in Treatment of Patients With Acute Drug-induced Liver Injury

The purpose of this study is to explore the efficacy and the safety of polyene phosphatidylcholine Injection in patients with acute drug-induced liver injury after 2-4 weeks of treatment.

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Key information

Conditions

Acute Drug Induced Liver Injury Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Liver Diseases Poisoning

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Hospital of Anhui Medical University, Hefei, Anhui, China

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About this study

This study is a phase IV study in subjects with acute drug-induced liver injury. As designed, the study will include a screening period of up to 1 week, 2 to 4 weeks of treatment, and 1 week of safety follow-up. The eligible subjects will randomly be assigned to polyene phosphatidylcholine group or magnesium isoglycyrrhizinate group to receive single-blind treatment with a ratio of 1:1.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 and ≤ 75 years, Male or female patients
  • Alanine aminotransferase (ALT) ≥ 3 x upper limit of normal (ULN) and Total bilirubin (TBIL) ≤ 5 x upper limit of normal (ULN)
  • The Roussel Uclaf Causality Assessment Method (RUCAM) score is more than or equal to 6 points. The patients with RUCAM score of 3-5 needs to be determined by all three investigators that the liver injury is likely to be caused by drugs
  • The duration of the current liver injury does not exceed 6 months

Exclusion criteria

  • Liver injury caused by other diseases, such as viral hepatitis, alcoholic and non-alcoholic fatty liver disease, or autoimmune liver disease
  • Acute liver failure or liver function decompensation, such as hepatic encephalopathy, ascites, albumin is less than 35g / L, the international standardized ratio (INR) of thrombin is more than 1.5
  • Anemia or thrombocytopenia, hemoglobin is below 80 g/L, platelet count below 50,000 platelets per microliter
  • Serum creatinine is more than 1.5 times ULN
  • Severe hypokalemia, severe hypernatremia
  • Patients have severe uncontrolled hypertension
  • Severe diseases of vital organs such as heart, lung, brain, kidney, and gastrointestinal tract
  • Treatment with polyene phosphatidylcholine injection or magnesium isoglycyrrhizinate injection within 5 days before informed consent
  • Allergy or intolerance to benzyl alcohol and study drugs
  • With no ability to express their complaints, such as mental illness and severe neurosis patient
  • Pregnant or breastfeeding women, fertile women or men are reluctant to use contraception to avoid pregnancy during the trial
  • Participation in another trial within 3 months before informed consent
  • Patients who are considered by the investigator as inappropriate for the trial for other reasons

Treatment and study plan

Polyene phosphatidylcholine injection 930 mg QD

Drug

Polyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.

Magnesium Isoglycyrrhizinate injection 200 mg QD

Drug

Magnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.

Primary outcomes

  1. Serum ALT normalization rate

    Time frame: After 2-4 weeks treatment

    The serum ALT normalization rate of treatment for 2-4 weeks

Secondary outcomes

  1. The serum ALT normalization rate for 1, 2 and 3 weeks

    Time frame: After 1, 2 and 3 weeks treatment

  2. Changes in serum ALT compared to the baseline for 1, 2, 3 and 4 weeks

    Time frame: After 1, 2, 3 and 4 weeks treatment

  3. The ratio of subjects whose ALT declined more than 50% compared to the base line for 1, 2, 3 and 4 weeks

    Time frame: After 1, 2, 3 and 4 weeks treatment

  4. The serum AST normalization rate for 1, 2, 3 and 4 weeks

    Time frame: After 1, 2, 3 and 4 weeks treatment

  5. Changes in serum AST compared to the baseline for 1, 2, 3 and 4 weeks

    Time frame: After 1, 2, 3 and 4 weeks treatment

  6. The serum TBIL normalization rate for 1, 2, 3 and 4 weeks

    Time frame: After 1, 2, 3 and 4 weeks treatment

  7. Changes in serum TBIL compared to the baseline for 1, 2, 3 and 4 weeks

    Time frame: After 1, 2, 3 and 4 weeks treatment

  8. Changes in serum ALP and GGT compared to the baseline for 1, 2, 3 and 4 weeks

    Time frame: After 1, 2, 3 and 4 weeks treatment

  9. The Incidence of Treatment-Emergent Adverse Events over time

    Time frame: After 2 to 4 weeks of treatment and 1 week of safety follow-up

Sponsors and collaborators

Lead sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Randomized, Single-blind, Active-controlled Trial of The Efficacy and Safety of Polyene Phosphatidylcholine in Patients With Acute Drug-induced Liver Injury

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2020
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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